Study of the Hemorai Vysio Wearable Device for Monitoring Changes Related to Blood Loss in Patients During and After Surgery. (VYSIO-FEASIBIL)
14. september 2026 opdateret af: Hemorai Inc
Feasibility Evaluation of a Strap-Based Wearable Optical Device (Hemorai Vysio) for Monitoring Hemodynamic Trends and Early Indicators of Blood Loss in Perioperative and Postoperative Patients
The goal of this clinical trial is to learn whether the Hemorai Vysio wearable device can be used safely and feasibly to track relative changes over time in tissue oxygen, hemoglobin-related signals, blood flow, and oxygen use during and after inpatient surgery. The device does not provide absolute clinical measurements. Researchers will also explore whether changes recorded by the device occur around signs or treatments related to blood loss.
The main questions are:
- Can the device collect usable information during and after surgery without interfering with routine care?
- What device-related problems, such as skin irritation or discomfort, occur?
- Do changes in the device measurements occur around changes in blood pressure, laboratory results, fluid administration, or blood transfusion?
- How comfortable and practical is the device for participants and bedside nurses?
Participants undergoing surgery will wear the device on the upper arm or chest. Trained study staff will apply it before surgery. It will remain in place for up to 48 hours after surgery, or until discharge or earlier removal. Participants will continue to receive usual hospital monitoring and care.
Bedside nurses may also join the study and complete a short voluntary survey. Nurses may check the device position and adjust the strap for comfort. They will not interpret the device measurements or use them to make treatment decisions.
Hemorai Vysio is an investigational device. Its measurements will be analyzed for research and will not be used to guide participants' medical care. Participants are not expected to receive a direct medical benefit from taking part.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
80
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Massachusetts
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Burlington, Massachusetts, Forenede Stater, 01805
- Lahey Clinic
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Kontakt:
- Shamsher Ali, MS, PhD
- Telefonnummer: 781-744-2629
- E-mail: Shamsher.Ali@lahey.org
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Kontakt:
- Deborah J Gannon, PhD
- Telefonnummer: 781-744-2734
- E-mail: Deborah.J.Gannon@lahey.org
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Ledende efterforsker:
- Elliot Servais, MD, FACS
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Inclusion Criteria:
Surgical participants:
- 18 to 85 years of age
- Undergoing inpatient surgery with an expected overnight hospital stay
- Capable of providing informed consent
- No anticipated contraindications to skin-worn sensors
- Hemodynamically stable at enrollment, with no vasopressor requirement
Nursing participants:
- Bedside nurse caring for an enrolled surgical participant during the Vysio device-wear period
- Capable of providing informed consent for the study-related usability survey
- Willing to complete the voluntary usability survey
Exclusion Criteria:
Surgical participants:
- Pregnancy; participants of childbearing potential with a positive pregnancy test before surgery
- Prisoner
- Cognitive impairment or inability to provide informed consent
- Hemodynamic instability requiring vasopressors at enrollment
- Severe dermatitis or another skin condition at the planned device application site
- Known allergy or prior adverse reaction to silicone elastomer, thermoplastic elastomer, or components of the self-adherent elastic wrap (cotton/polyester substrate or synthetic elastic yarn)
- Active skin breakdown, dermatitis, eczema, burns, or a surgical incision at the planned strap contact site
- Condition compromising skin integrity such that the site would not qualify as intact skin under ISO 10993-1:2018
Nursing participants:
- Not caring for an enrolled surgical participant during the Vysio device-wear period
- Unable or unwilling to provide informed consent
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Enhedens gennemførlighed
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Hemorai Vysio Monitoring
Adult surgical participants will wear the investigational Hemorai Vysio device on the upper arm or chest during surgery and for up to 48 hours after surgery, or until earlier discharge, withdrawal, or clinically indicated removal.
The device records research-only optical signals in parallel with standard care.
Device data will be analyzed offline and will not be used to guide clinical decisions.
|
An investigational, non-FDA-approved strap-based wearable optical device placed on the upper arm or chest by trained study staff.
It records intermittent 2-minute optical signal windows every 15 minutes during surgery and for up to 48 hours postoperatively.
Research outputs include relative trends in local tissue oxygenation (StO2), hemoglobin-related signals, perfusion index (SFI), and tissue oxygen consumption (tMRO2).
The device operates in parallel with standard-of-care monitoring; data are analyzed offline and are not used for clinical decisions.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of scheduled Vysio recording windows containing signal data
Tidsramme: From device placement before surgery through device removal, up to approximately 54 hours
|
For each patient participant, the number of scheduled 2-minute Vysio recording windows containing recorded signal data will be divided by the number of scheduled windows during device wear and multiplied by 100.
The percentage will be summarized descriptively across participants as a measure of device-data completeness.
|
From device placement before surgery through device removal, up to approximately 54 hours
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Descriptive Relative Tissue Oxygenation (StO2) Trajectory by Hemorrhage-Protocol Activation Status
Tidsramme: From device placement before surgery through device removal, up to approximately 54 hours
|
Relative local tissue oxygenation (StO2) trajectories recorded by Vysio will be summarized descriptively for surgical participants with a Lahey clinical-team-defined hemorrhage-protocol activation during device wear and those without an activation (routine postoperative recovery group).
Values will also be time-aligned with documented hypotension, transfusion, fluid administration, and serial hemoglobin and hematocrit results.
Pearson or Spearman correlations may be calculated where appropriate.
Analyses are exploratory and will not estimate diagnostic performance.
|
From device placement before surgery through device removal, up to approximately 54 hours
|
|
Descriptive Vysio Hemoglobin-Related Signal Trajectory by Hemorrhage-Protocol Activation Status
Tidsramme: From device placement before surgery through device removal, up to approximately 54 hours
|
Relative hemoglobin-related signal trajectories recorded by Vysio will be summarized descriptively for surgical participants with a Lahey clinical-team-defined hemorrhage-protocol activation during device wear and those without an activation (routine postoperative recovery group).
These device-derived relative trends are not systemic hemoglobin concentrations.
Values will be time-aligned with documented hypotension, transfusion, fluid administration, and serial laboratory hemoglobin and hematocrit results.
Pearson or Spearman correlations may be calculated where appropriate.
Analyses are exploratory and will not estimate diagnostic performance.
|
From device placement before surgery through device removal, up to approximately 54 hours
|
|
Descriptive Vysio Perfusion Index (SFI) Trajectory by Hemorrhage-Protocol Activation Status
Tidsramme: From device placement before surgery through device removal, up to approximately 54 hours
|
Relative perfusion index (SFI) trajectories recorded by Vysio will be summarized descriptively for surgical participants with a Lahey clinical-team-defined hemorrhage-protocol activation during device wear and those without an activation (routine postoperative recovery group).
SFI is a relative device-derived perfusion trend and not an absolute tissue perfusion measurement.
Values will be time-aligned with documented hypotension, transfusion, fluid administration, and serial hemoglobin and hematocrit results.
Pearson or Spearman correlations may be calculated where appropriate.
Analyses are exploratory and will not estimate diagnostic performance.
|
From device placement before surgery through device removal, up to approximately 54 hours
|
|
Descriptive Vysio Tissue Oxygen Consumption (tMRO2) Trajectory by Hemorrhage-Protocol Activation Status
Tidsramme: From device placement before surgery through device removal, up to approximately 54 hours
|
Relative tissue oxygen consumption (tMRO2) trajectories recorded by Vysio will be summarized descriptively for surgical participants with a Lahey clinical-team-defined hemorrhage-protocol activation during device wear and those without an activation (routine postoperative recovery group).
tMRO2 is a relative device-derived trend and not an absolute calibrated metabolic rate.
Values will be time-aligned with documented hypotension, transfusion, fluid administration, and serial hemoglobin and hematocrit results.
Pearson or Spearman correlations may be calculated where appropriate.
Analyses are exploratory and will not estimate diagnostic performance.
|
From device placement before surgery through device removal, up to approximately 54 hours
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Elliot Servais, MD, FACS, Lahey Clinic, Inc.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
15. oktober 2026
Primær færdiggørelse (Anslået)
1. maj 2027
Studieafslutning (Anslået)
30. september 2027
Datoer for studieregistrering
Først indsendt
14. september 2026
Først indsendt, der opfyldte QC-kriterier
14. september 2026
Først opslået (Faktiske)
17. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
17. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Vy4-2026-01
- 20964 (Andet bevillings-/finansieringsnummer: Center for Advancing Point of Care Technologies (CAPCaT))
- 1U54HL143541 (U.S. NIH-bevilling/kontrakt)
- 20263012 (Anden identifikator: Lahey Clinic, Inc. Institutional Review Board)
- 2414660-1 (Anden identifikator: IRBNet / Lahey Clinic, Inc.)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
There is no current plan to make individual participant data available to researchers outside the IRB-approved study team.
De-identified study data will be stored on a secure Hemorai server, with access limited to trained, IRB-approved study team members.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ja
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
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